Coding Specialist II (Clinical Data Coding)
Location: Bangalore, India (Remote)
Job Type: Full-Time
Department: Clinical Data Management / Medical Coding
Job Summary
We are seeking an experienced Coding Specialist II to support clinical data coding activities across global clinical trials. This role is responsible for ensuring accurate, consistent, and timely medical coding of clinical trial data using industry-standard coding dictionaries such as MedDRA and WHODrug. The successful candidate will provide technical oversight for coding processes, collaborate with cross-functional stakeholders, and contribute to high-quality clinical data delivery while maintaining compliance with regulatory and industry standards.
Experience Required
5–7 years of experience in Clinical Data Coding or Clinical Data Management.
Hands-on experience with MedDRA and WHODrug coding.
Experience working on global clinical trials within a CRO, pharmaceutical, or biotechnology environment.
Educational Qualification
Bachelor's or Master's Degree in Life Sciences, Pharmacy, Biotechnology, Nursing, Medical Laboratory Technology, or related healthcare discipline.
Equivalent industry experience may be considered.
MedDRA Certification is preferred.
Key Responsibilities
Perform medical coding activities independently across assigned clinical studies and programs.
Ensure accurate coding of adverse events, medical histories, concomitant medications, and other clinical data using standard coding dictionaries.
Manage thesaurus and dictionary-related activities including coding review, maintenance, verification, and reconciliation.
Collaborate with Clinical Data Managers, Medical Monitors, Biostatisticians, Clinical Operations teams, and Safety teams to support study deliverables.
Review and contribute to Data Management Plans, coding conventions, and study-specific coding specifications.
Monitor coding quality, timelines, and project deliverables while ensuring compliance with study requirements.
Provide coding status updates and act as a liaison between coding teams and project stakeholders.
Support study startup, conduct, database lock, and closeout activities related to coding.
Assist in dictionary verification and implementation of sponsor-specific coding requirements.
Identify coding issues, recommend solutions, and contribute to continuous process improvements.
Participate in the development and enhancement of SOPs, work instructions, and coding best practices.
Stay updated with evolving coding standards, regulatory requirements, and industry trends.
Required Skills
Strong expertise in MedDRA and WHODrug coding.
Experience with coding platforms such as Medidata Coder, Central Coding, or equivalent systems.
Thorough understanding of clinical trial processes and clinical data management workflows.
Knowledge of ICH-GCP guidelines and global regulatory requirements.
Strong understanding of thesaurus management and medical terminology.
Excellent analytical, problem-solving, and decision-making skills.
Strong communication and stakeholder management abilities.
Ability to manage multiple studies and competing priorities effectively.
Preferred Qualifications
MedDRA Certification.
Experience supporting global clinical development programs.
Knowledge of coding governance, coding quality review processes, and dictionary management.
Familiarity with CRO and pharmaceutical industry operating models.
Experience contributing to process improvement and quality initiatives.
Key Technical Skills
MedDRA Coding
WHODrug Coding
Medical Terminology
Clinical Data Management
Medidata Coder
Central Coding Platforms
Clinical Trial Data Review
Dictionary Management
Data Quality Review
ICH-GCP Compliance
Regulatory Standards
Career Growth Opportunities
This role offers progression opportunities into Senior Coding Specialist, Medical Coding Lead, Clinical Data Management Lead, Global Data Standards Specialist, Clinical Data Governance, and Clinical Data Operations leadership roles within pharmaceutical, biotechnology, and CRO organizations.
Uttar Pradesh :
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